Clinical trial · Interventional
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy. The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation. A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out. Then, the incidence of CRBD was compared between the two groups.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lidocaine and sufentanil | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lidocaine + sufentanil intervention group
- interventionNames
- Drug: lidocaine and sufentanil
- type
- PLACEBO_COMPARATOR
- label
- Saline control group
- interventionNames
- Drug: Saline
Primary outcomes (1)
- measure
- incidence of CRBD
- timeFrame
- immediately after extubation in resuscitation
- description
- incidence of CRBD
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. aged 18-79 years, ASA class I-II 2. participants undergoing robot-assisted radical prostatectomy under general anesthesia 3. signed informed consent and volunteered to participate in the experiment Exclusion Criteria: 1. urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization 2. a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder 3. cognitive impairment or communication disorders 4. severe heart, lung, liver, kidney and immune system diseases 5. confirmed or suspected allergy to this trial drug
References
Publications (0)
Data not yet available